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Initial Importer and ISO 13485 (MDSAP) - Will the US company be included?

If a parent company has a branch in the US who acts as the initial importer, is the parent or head office required to do an internal audit of the US distributor/initial importer? Note: the parent company has full control of the child initial importer. For the MDSAP audit of the head office covering both US and Canada requirements, will the US company be included in the MDSAP scope or will there be questions regarding this entity? Thank you.

Ajit Basrur

Staff member
MDSAP audits do not extend to Initial Importer.

In MDSAP, the audits are done only for "manufacturers" who have the responsibility for design and/or manufacture of a medical device. Since the Initial Importer is not involved with changing the existing labeling is not considered a manufacturer.

From FDA, an initial importer is any importer who furthers the marketing of a device from a foreign manufacturer to the person who makes the final delivery or sale of the device to the ultimate consumer or user, but does not repackage, or otherwise change the container, wrapper, or labeling of the device or device package.
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